ValuRx Dye Free Allergy Relief

DIPHENHYDRAMINE HCL 25 MG ORAL HUMAN OTC DRUG

ValuRx Dye Free Allergy Relief is an FDA drug label for the active ingredient DIPHENHYDRAMINE HCL 25 MG manufactured by Shield Pharmaceuticals Corp administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260804.

Generic name
DIPHENHYDRAMINE HCL 25 MG
Manufacturer
Shield Pharmaceuticals Corp
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
83059-0167
Application
M012
Label effective
20260804

About this product

ValuRx Dye Free Allergy Relief is an FDA-registered drug product whose active ingredient is DIPHENHYDRAMINE HCL 25 MG. It is labelled by Shield Pharmaceuticals Corp taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 83059-0167, application M012, label effective 20260804. It is one of 3 FDA drug label records sharing the active ingredient DIPHENHYDRAMINE HCL 25 MG. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing DIPHENHYDRAMINE HCL 25 MG are most often described in connection with: temporarily relieves, symptoms due, runny nose, hay fever, upper respiratory, itchy watery, eyes sneezing, common cold. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredient (in each softgel) Diphenhydramine HCl 25 mg

Indications & Usage

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat temporarily relieves these symptoms due to the common cold: runny nose sneezing

Dosage & Administration

Directions take every 4 to 6 hours, or as directed by a doctor do not take more than 6 times in 24 hours adults and children 12 years and over 1 to 2 softgels children 6 to under 12 years 1 softgel children under 6 years do not use

Warnings

Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

More products with the same ingredient

DIPHENHYDRAMINE HCL 25 MG

Nighttime Sleep Aid

Health Pharma USA LLC View label

Sleep Aid

Allegiant Health View label

How products containing DIPHENHYDRAMINE HCL 25 MG compare

FDA lists 3 drug label records with DIPHENHYDRAMINE HCL 25 MG as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — Allegiant Health 1
— — Health Pharma USA LLC 1
— — Shield Pharmaceuticals Corp 1
— — — —
— — — —

Frequently asked questions

What is ValuRx Dye Free Allergy Relief used for?
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat temporarily relieves these symptoms due to the common cold: runny nose sneezing

Who makes ValuRx Dye Free Allergy Relief?
Shield Pharmaceuticals Corp is the labeler of record for ValuRx Dye Free Allergy Relief. 3 FDA label records share the active ingredient DIPHENHYDRAMINE HCL 25 MG, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does ValuRx Dye Free Allergy Relief come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is ValuRx Dye Free Allergy Relief prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing DIPHENHYDRAMINE HCL 25 MG?
Yes. 3 FDA drug label records list DIPHENHYDRAMINE HCL 25 MG as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has ValuRx Dye Free Allergy Relief been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.